EURO-STIM Registry

Sponsor
Inspire Medical Systems, Inc.
Study ID
NCT06971796
Status
Recruiting
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Conditions

  • Obstructive Sleep Apnea
  • Obstructive Sleep Apnea (OSA)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Inspire UAS System — DEVICE
    Participants will be implanted with the Inspire UAS System, which is a permanent, implantable therapy that consists of three implantable components: an IPG, a stimulation lead, and a sensing lead. In addition, the study subject receives a remote control to activate the therapy.

Study Details

The registry is to measure longitudinal outcomes and adherence of the Inspire System. The goal of the registry is to capture the life cycle of the patient's use of the Inspire System through routine clinical care visits. There are no required interventions or testing.

Key Dates

First listed
May 14, 2025
Start date
May 26, 2025
Status verified
Apr 2025
Primary completion
Apr 30, 2035
Completion
Apr 30, 2035

Study Design

Enrollment
1,000 participants (estimated)

Primary Outcome Measure

Apnea Hypopnea Index (AHI) [ Time Frame: Total AHI, supine and non-supine AHI, documented as events/hour of sleep will be collected at baseline, prior to implant, and at follow-up visits, if available, as determined by clinical standard of care. ]

Central Contacts

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